MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA MARKER; BIOPSY MARKER

Model Number	SMEC10R
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for poor quality image as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model smec10r biopsy marker allegedly produced a poor quality image.This information was received from one source.The one malfunction involved one patient with no patient consequences.The patient is female but the age and weight were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model smec10r biopsy marker allegedly produced a poor quality image.This information was received from one source.The one malfunction involved one patient with no patient consequences.The patient is 76 kgs, female but the age was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for poor quality image as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• Brand Name: SENOMARK ULTRA MARKER
• Common Device Name: BIOPSY MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9200138
• Report Number: 2020394-2019-04041
• Device Sequence Number: 11539872
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTDP00127
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1
• Patient Age: 74 YR